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Hyatt Regency Bethesda

2015年4月13日 (月) 午前 7:00 - 2015年4月15日 (水) 午後 12:00

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

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Session 6A: Process Validation/Verification - Chemicals

Session Chair(s)

Kevin Seibert, PHD, MS

Kevin Seibert, PHD, MS

Engineering Fellow, Synthetic Molecule Design and Development, Eli Lilly and Company, United States

With the changing landscape of small molecule syntheses, and the implementation of many Quality by Design principles into the drug development as well as commercialization activities, traditional approaches to process validation may not provide a sufficient data package or confidence to ensure robust long term manufacture. Infrequent production, desired flexibility, and alternative synthetic platforms (i.e. flow chemistry) offer unique challenges and therefore validation or ongoing verification strategies that support these activities need to be considered. This session will provide examples of validation and verification strategies useful for addressing the changing regulatory landscape. Time will be reserved for a panel discussion and audience participation is highly encouraged.

Speaker(s)

Kevin Seibert, PHD, MS

Kevin Seibert, PHD, MS

Engineering Fellow, Synthetic Molecule Design and Development, Eli Lilly and Company, United States

Validation Challenges of a Small Molecule Flow Chemistry Process

Christine Capacci-Daniel, PHD

Christine Capacci-Daniel, PHD

Consumer Safety Officer, Office of Process & Facilities, OPQ, CDER, FDA, United States

FDA Perspective

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